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54.193.210.162
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Submitted URL: https://click.mailer.grcforte.com/?qs=c7e96975034f2c017ff6c84b4fb48e0edfa241a92eac1b3fea3827057e7db9afb4f7e232b5a021ca1e59e67e7638...
Effective URL: https://www.grciq.com/trainings/livewebinar/6070/the-11-must-have-documents-of-software-verification-and-validation
Submission: On January 04 via api from US — Scanned from DE
Effective URL: https://www.grciq.com/trainings/livewebinar/6070/the-11-must-have-documents-of-software-verification-and-validation
Submission: On January 04 via api from US — Scanned from DE
Form analysis 5 forms found in the DOM
POST /ShoppingCart/TopHeaderSearchTraining
<form action="/ShoppingCart/TopHeaderSearchTraining" id="HeaderSearch" method="post" novalidate="novalidate">
<input type="checkbox" class="search-checkbox" id="searchcheckbox">
<div class="d-flex justify-content-center align-items-center search-container">
<div class="w-75 d-flex justify-content-center align-items-center">
<div class="input-field mrg-top20 width-280">
<div class="select-wrapper"><input class="select-dropdown dropdown-trigger" type="text" readonly="true" data-target="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce07">
<ul id="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce07" class="dropdown-content select-dropdown" tabindex="0">
<li id="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce070" tabindex="0" class="selected"><span>All Industries</span></li>
<li id="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce071" tabindex="0"><span>Banking & Insurance</span></li>
<li id="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce072" tabindex="0"><span>Food & Dietary Supplements</span></li>
<li id="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce073" tabindex="0"><span>Hospital & Healthcare</span></li>
<li id="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce074" tabindex="0"><span>Human Resources</span></li>
<li id="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce075" tabindex="0"><span>Life Sciences</span></li>
<li id="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce076" tabindex="0"><span>Manufacturing</span></li>
<li id="select-options-c834542d-304d-6cff-7bd9-26ed0f03ce077" tabindex="0"><span>Multi Industry</span></li>
</ul><svg class="caret" height="24" viewBox="0 0 24 24" width="24" xmlns="http://www.w3.org/2000/svg">
<path d="M7 10l5 5 5-5z"></path>
<path d="M0 0h24v24H0z" fill="none"></path>
</svg><select id="Industry" name="Industry" tabindex="-1">
<option value="">All Industries</option>
<option value="4">Banking & Insurance</option>
<option value="32">Food & Dietary Supplements</option>
<option value="17">Hospital & Healthcare</option>
<option value="18">Human Resources</option>
<option value="48">Life Sciences</option>
<option value="78">Manufacturing</option>
<option value="56">Multi Industry</option>
</select>
</div>
<label for="Industries">Select Indusry</label>
</div>
<div class="input-field flex-grow-1 mrg-top20">
<input type="text" name="HeaderKeyWord" id="HeaderKeyWord">
<label for="HeaderKeyWord">Type your search here</label>
</div>
<div>
<button type="submit" value="Search" class="marketing-nav__button marketing-button marketing-button--small discount-button">Search</button>
</div>
</div>
<label class="fa fa-close" for="searchcheckbox"></label>
</div>
</form>POST /shoppingcart/addtocart
<form action="/shoppingcart/addtocart" id="addtocartform" method="post" novalidate="novalidate">
<input type="submit" class="default-btn cart-btn cart-option" value="Add to cart">
<input type="hidden" name="PayOpt" id="PayOpt"><input type="hidden" name="prodname" id="prodid" value="IQW22K1123"><input type="hidden" name="trainingSlNo" id="trainingSlNo" value="6070">
</form><form novalidate="novalidate">
<div class="product-pricing-container mrg-btm20">
<div class="top-box-shadow product-add-to-cart hide">
<div class="pad-10 text-center min-height-auto">
<div class="free-pricing-container">
</div>
<label class="font-xxl">
</label>
<a id="addtocart-middle2" class="marketing-nav__button marketing-button marketing-button--small discount-button animated-icon">Register for Free<i class="fa fa-shopping-cart mrg-lft10 right" aria-hidden="true"></i></a>
<label class="font-xxl">
</label>
</div>
</div>
<div class="card show" id="package-cart-item">
<div class="top-box-shadow product-add-to-cart">
<div class="pad-10 text-center vertical-center min-height-auto space-between">
<div class="col-xs-7 clear-padding">
<label class="font-14">Was: <span class="color-accent-red striked" id="was-price-to-pay1" style="display: inline;">$155</span></label>
<label class="font-16 pad-btm0 pad-top0">Now: <span id="total-price-to-pay1" class="color-blue font-xxl" style="margin-right: -15px; display: inline;">$119</span></label>
<label class="font-14">You Save: <span class="color-accent-red" id="was-discount-to-pay1" style="display: inline;">$36(30%)</span></label>
</div>
<div class="col-xs-5 clear-padding">
<a id="addtocart-middle1" class="p-3 marketing-nav__button marketing-button marketing-button--small discount-button animated-icon">Add to Cart</a>
</div>
</div>
</div>
<div class="card-content">
<div class="row negative-margin mrg-btm0">
<div class="filter-section-criteria col-xs-12">
<div class="row green-checkbox">
<div class="pad-10 bg-blue mrg-btm15 text-center">
<label class="color-blue font-bold clear-padding font-18">Live Webinar</label>
</div>
<div class="pad-x-15">
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184420" productprice="119.00" value="184420" class="level select-package filled-in" type="checkbox">
<span>1 Attendee - $119</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184420" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Certificate of Participation for Attendee</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184421" productprice="169.00" value="184421" class="level select-package filled-in" type="checkbox">
<span>2 Attendees - $169 (SAVE $69)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184421" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Add/ Edit attendees using My Account</li>
<li> Certificate of Participation for All Attendees</li>
</ul>
</label>
</div>
<div id="more-attendees-div" style="display: none;">
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184422" productprice="199.00" value="184422" class="level select-package filled-in" type="checkbox">
<span>3 Attendees - $199 (SAVE $158)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184422" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Add/ Edit attendees using My Account</li>
<li> Certificate of Participation for All Attendees</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184423" productprice="259.00" value="184423" class="level select-package filled-in" type="checkbox">
<span>4 Attendees - $259 (SAVE $217)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184423" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Add/ Edit attendees using My Account</li>
<li> Certificate of Participation for All Attendees</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184424" productprice="289.00" value="184424" class="level select-package filled-in" type="checkbox">
<span>5 Attendees - $289 (SAVE $306)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184424" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Add/ Edit attendees using My Account</li>
<li> Certificate of Participation for All Attendees</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184425" productprice="319.00" value="184425" class="level select-package filled-in" type="checkbox">
<span>6 Attendees - $319 (SAVE $395)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184425" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Add/ Edit attendees using My Account</li>
<li> Certificate of Participation for All Attendees</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184426" productprice="349.00" value="184426" class="level select-package filled-in" type="checkbox">
<span>7 Attendees - $349 (SAVE $484)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184426" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Add/ Edit attendees using My Account</li>
<li> Certificate of Participation for All Attendees</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184427" productprice="369.00" value="184427" class="level select-package filled-in" type="checkbox">
<span>8 Attendees - $369 (SAVE $583)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184427" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Add/ Edit attendees using My Account</li>
<li> Certificate of Participation for All Attendees</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184428" productprice="399.00" value="184428" class="level select-package filled-in" type="checkbox">
<span>9 Attendees - $399 (SAVE $672)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184428" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Add/ Edit attendees using My Account</li>
<li> Certificate of Participation for All Attendees</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184429" productprice="419.00" value="184429" class="level select-package filled-in" type="checkbox">
<span>10 Attendees - $419 (SAVE $771)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184429" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Add/ Edit attendees using My Account</li>
<li> Certificate of Participation for All Attendees</li>
</ul>
</label>
</div>
</div>
<p class="position-relative">
<label>
<span id="more-attendees" class="font-16 cursor-pointer text-underline color-green center-align">
<i class="Tiny material-icons vert-align-top">expand_more</i>
<span>More Attendees</span></span>
<span id="less-attendees" class="font-16 cursor-pointer text-underline color-green center-align" style="display: none;">
<i class="Tiny material-icons vert-align-top">expand_less</i>
<span>Less Attendees</span> </span>
</label>
</p>
<p class="font-14 pad-top5f"> What if you miss the Live Webinar?<br> Don't worry! Pay only $29 & get the full Recording. </p>
</div>
</div>
<div class="row green-checkbox">
<div class="pad-10 bg-blue mrg-btm15 text-center">
<label class="color-blue font-bold clear-padding font-18">Recorded Options</label>
</div>
<div class="pad-x-15">
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184443" productprice="319.00" value="184443" class="level select-package filled-in" type="checkbox">
<span>$319.00 : Recording - Multi. Licence</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184443" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Upto 10 users get access</li>
<li> Add users using My Account</li>
<li> Available in 24 hours after Live Event</li>
<li> Play video on the website itself</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184432" productprice="269.00" value="184432" class="level select-package filled-in" type="checkbox">
<span>$269.00 : Transcript</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184432" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>PDF Transcript of Training</li>
<li> Available in 2 business days, after Live Event</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184431" productprice="179.00" value="184431" class="level select-package filled-in" type="checkbox">
<span>$179.00 : DVD/USB</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184431" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Shipping in 5 business days after Live Event</li>
<li> Free shipping within the US</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184430" productprice="149.00" value="184430" class="level select-package filled-in" type="checkbox">
<span>$149.00 : Recording - Single Licence</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184430" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li>Play video on the website itself</li>
<li> Available in 24 hours after Live Event</li>
</ul>
</label>
</div>
</div>
</div>
<div class="row green-checkbox">
<div class="pad-10 bg-blue mrg-btm15 text-center">
<label class="color-blue font-bold clear-padding font-18">Value Packs</label>
</div>
<div class="pad-x-15">
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184416" productprice="469.00" value="184416" class="level select-package filled-in" type="checkbox">
<span>$469.00 : Group Live (10) + DVD/USB</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184416" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li class="pack-info-desc-item"><u class="font-bold">Group Live (10):</u></li>
<li> Upto 10 users get access</li>
<li> Add/ Edit attendees using My Account</li>
<li> Access notification 24 hrs before Event to All</li>
<li> Access notification via. Email & My Account to All</li>
<li> Certificate of Participation for All Attendees</li>
<li class="pack-info-desc-item"> <u class="font-bold">DVD/USB:</u></li>
<li> Shipping in 3 business days (in US), after Live Event</li>
<li> Free shipping within the US</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184444" productprice="469.00" value="184444" class="level select-package filled-in" type="checkbox">
<span>$469.00 : Group Live (10) + Recording(10)</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184444" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li class="pack-info-desc-item"><u class="font-bold">Group Live (10):</u></li>
<li> Upto 10 users get access</li>
<li> Add/ Edit attendees using My Account</li>
<li> Access notification 24 hrs before Event to All</li>
<li> Access notification via. Email & My Account to All</li>
<li> Certificate of Participation for All Attendees</li>
<li class="pack-info-desc-item"> <u class="font-bold">Recording (10):</u></li>
<li> Same 10 users get recording access</li>
<li> Available 24 hours after Live Event</li>
<li> Play video on the website itself</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184445" productprice="269.00" value="184445" class="level select-package filled-in" type="checkbox">
<span>$269.00 : Recording(1) + Transcript</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184445" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li class="pack-info-desc-item"><u class="font-bold">Recording (1):</u></li>
<li> Play video on the website itself</li>
<li> Available 24 hours after Live Event</li>
<li> Recording(digital) access for 6 months</li>
<li class="pack-info-desc-item"> <u class="font-bold">Transcript:</u></li>
<li> PDF Transcript of Training</li>
<li> Available in 2 business days, after Live Event</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184415" productprice="219.00" value="184415" class="level select-package filled-in" type="checkbox">
<span>$219.00 : Live (1) + DVD/USB</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184415" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li class="pack-info-desc-item"><u class="font-bold">Live (1):</u></li>
<li> Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Certificate of Participation for Attendee</li>
<li class="pack-info-desc-item"> <u class="font-bold">DVD/USB:</u></li>
<li> Shipping in 3 business days (in US), after Live Event</li>
<li> Free shipping within the US</li>
</ul>
</label>
</div>
<p class="position-relative">
<label>
<input name="price" id="selectedPrice_184414" productprice="169.00" value="184414" class="level select-package filled-in" type="checkbox">
<span>$169.00 : Live (1) + Recording</span>
</label>
<i class="fa fa-info-circle cursor-pointer" id="info-package-184414" aria-hidden="true"></i>
</p>
<div class="information-container pad-10 bg-grey">
<label class="custom-popover-content unbold">
<ul>
<li class="pack-info-desc-item"><u class="font-bold">Live (1):</u></li>
<li> Access notification 24 hrs before Event</li>
<li> Access notification via. Email & My Account</li>
<li> Certificate of Participation for Attendee</li>
<li class="pack-info-desc-item"> <u class="font-bold">Recording:</u></li>
<li> Play video on the website itself</li>
<li> Available in 24 hours after Live Event</li>
</ul>
</label>
</div>
</div>
</div>
</div>
</div>
</div>
<div class="top-box-shadow product-add-to-cart">
<div class="pad-10 text-center vertical-center min-height-auto space-between">
<div class="col-xs-7 clear-padding">
<label class="font-14">Was: <span class="color-accent-red striked" id="was-price-to-pay" style="display: inline;">$155</span></label>
<label class="font-16 pad-btm0 pad-top0">Now: <span id="total-price-to-pay" class="color-blue font-xxl" style="margin-right: -15px; display: inline;">$119</span></label>
<label class="font-14">You Save: <span class="color-accent-red" id="was-discount-to-pay" style="display: inline;">$36(30%)</span></label>
</div>
<div class="col-xs-5 clear-padding">
<a id="addtocart-middle" class="p-3 marketing-nav__button marketing-button marketing-button--small discount-button animated-icon">Add to Cart</a>
</div>
</div>
</div>
</div>
<div class="card">
<div>
<div class="min-height-auto pad-10 space-between text-center">
<img src="https://ciq-s3.s3.us-west-1.amazonaws.com/Common/Images/money-back-100.png" width="145" height="135">
<div>
<h3 class="bold">100% MONEY BACK GUARANTEED</h3>
<a href="/refund-policy" target="_blank" class="text-success text-underline">Refund / Cancellation policy</a>
</div>
</div>
</div>
</div>
<div class="alert alert-warning text-center"> For group or any booking support, contact: <div class="pad-10">
<i class="fa fa-envelope-o mrg-rt5 color-brand"></i><a href="#" mailto="contactus@grciq.com">contactus@grciq.com</a>
</div>
<div>
<i class="fa fa-phone mrg-rt5 color-brand"></i>
<a href="#" tel="+1-800-498-2906 (US Toll Free)">+1-800-498-2906 (US Toll Free)</a>
</div>
</div>
<div class="row">
<div class="flex space-between">
<div class="sharethis-inline-share-buttons st-center st-has-labels st-inline-share-buttons st-animated" data-url="http://grciq.com/trainings/livewebinar/6070/the-11-must-have-documents-of-software-verification-and-validation" id="st-1">
<div class="st-btn st-first st-last st-remove-label" data-network="whatsapp" style="display: inline-block;">
<img alt="whatsapp sharing button" src="https://platform-cdn.sharethis.com/img/whatsapp.svg">
<span class="st-label">Share</span>
</div>
</div>
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Webinars Instant Transcripts Support * * All Recordings Pass Sign In Sign Up * 0 * THE 11 MUST-HAVE DOCUMENTS OF SOFTWARE VERIFICATION AND VALIDATION Schedule Wednesday, January 11, 2023 || 10:00 AM PST | 01:00 PM EST Duration 90 Mins Level Basic & Intermediate Webinar ID IQW22K1123 WHAT YOU'LL LEARN? ADD TO WISHLIST • Verification or Validation -- FDA Expectations • The Project Validation Plan • An FDA-accepted Documentation "Model" • Product and Process / Test / Facilities / Equipment Software V&V • When and How to Use DQ, IQ, OQ, PQ (or their equivalents) • The FDA’s 11 Key V&V Documentation Elements • “White Box” and “Black Box” Validations • GAMP® / Other Considerations OVERVIEW OF THE WEBINAR The verification and validation of medical industry software are coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the FDA, GAMP®, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, and their real-world implementation. If will focus on the 11 key software documents from an FDA Guidance Document. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if “risk-based”. How can this be done in the "real world". This webinar will address software that is: 1. As-Product; 2. In-Product; 3. Process and/or In Production and Test Equipment; and 4. The Quality System / CGMPs. A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process. WHO SHOULD ATTEND? • Senior management in Drugs, Devices, Combination Products, Biologics, Dietary Supplements • QA / RA • Software development, programming, documentation, testing teams • R&D • Engineering • Production • Operations • Consultants; others tasked with product, process, electronic records software V&V responsibilities WHY SHOULD YOU ATTEND? The software has become pervasive in medical devices themselves, and in the controlling, running, and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics, or dietary supplements industries. • A quick review of Internet forums will show much confusion about the subject. Software is being developed for medical imaging and even thought control of computers. It is increasingly being used for e-records and e-signatures. • The U.S. FDA rightly recognizes that virtually all software quality problems occur in the design, testing, and validation phases since the replication of software are relatively defect-free. Regulatory auditors are more comfortable with delving into software issues. • Effective and real-world software V&V is even more important in today’s resource-constrained industrial environment. This discussion will focus on a preferred U.S. FDA documentation "model" in various software/firmware applications, including ERP, in-device, as-device, process/equipment control, and cGMP data / 21 CFR Part 11 applications. FACULTY - MR.JOHN E. LINCOLN John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA. 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